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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029493
Receipt No. R000033094
Scientific Title Comparison of the cleanliness of the operative field in cataract surgery between intraoperative iodine and preoperative antibiotic drops..
Date of disclosure of the study information 2017/10/12
Last modified on 2017/10/10

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Basic information
Public title Comparison of the cleanliness of the operative field in cataract surgery between intraoperative iodine and preoperative antibiotic drops..
Acronym Comparison between intaraoperative iodine and preoperative antibiotic drops.
Scientific Title Comparison of the cleanliness of the operative field in cataract surgery between intraoperative iodine and preoperative antibiotic drops..
Scientific Title:Acronym Comparison between intaraoperative iodine and preoperative antibiotic drops.
Region
Japan

Condition
Condition Cataract
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the hypothesis that the intraoperative iodine application attains the efficient cleanliness of the operative field during the
cataract surgery without preoperative antibiotic eyedrops.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The copy number of the polymerase chain reaction and bacterial flora amount of the operative field in cataract surgery.
Key secondary outcomes vision
grade of flare
endophthalmitis

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine Maneuver
Interventions/Control_1 Former eye: Intraoperative iodine compound disinfection for surgical field without preoperative antibiotics
Interventions/Control_2 Second eye: Preoperative antibiotic application without intraoperative iodine disinfection.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients undergoing cataract surgery.
Key exclusion criteria Patients with pre-existing blepharitis, conjunctivitis, keratitis, or uveitis.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kauki Matsuura
Organization NOjimahospital
Division name Ophthalmology
Zip code
Address 2514-1, Sezaki-cho, Kurayoshi, Tottori
TEL 0858-22-6231
Email matsu224@ncn-k.net

Public contact
Name of contact person
1st name
Middle name
Last name Kauki Matsuura
Organization NOjimahospital
Division name Ophthalmology
Zip code
Address 2514-1, Sezaki-cho, Kurayoshi, Tottori
TEL 0858-22-6231
Homepage URL
Email matsu224@ncn-k.net

Sponsor
Institute Nojima hospital
Institute
Department

Funding Source
Organization Nojima hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 12 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2017 Year 09 Month 29 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 10 Day
Last modified on
2017 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033094

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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